Computer System Validation (CSV) Specialist

HIRING: Computer System Validation (CSV) Specialist

Locations: Hyderabad | Bengaluru | Chennai | Pune

Shift: 12 PM – 9 PM

Experience: 4–8 Years

CTC: ₹14–15 LPA

Domain: CSV | GPV | GxP

Role Overview

We are looking for an experienced Computer System Validation (CSV) professional with strong exposure to GxP-regulated environments and validation processes. The ideal candidate should have hands-on experience in CSV activities and a good understanding of regulatory compliance and quality systems.

Key Responsibilities

• Execute and support Computer System Validation (CSV) activities across the system lifecycle.
• Prepare/review validation documentation including URS, Risk Assessment, IQ/OQ/PQ, validation plans and reports.
• Ensure compliance with GxP, FDA and applicable regulatory requirements.
• Support audits, deviations, CAPA and change-control activities.
• Work with cross-functional teams to ensure validated systems remain compliant.
• Maintain validation documentation and traceability.

Required Skills

4–8 years of relevant CSV experience

Strong knowledge of GxP / GMP / regulatory compliance

Experience with CSV lifecycle and validation documentation

Knowledge of risk assessment, change control, deviation & CAPA

Good communication and stakeholder-management skills

Exposure to GPV / Pharmacovigilance environments is an advantage